Anatomic Shoulder Prosthesis 04.01.0001Recalls & reported problems
Medacta International SA · Standard Humeral Diaphysis – Cementless, Size 6 · Class 2 · Implant
All models of Anatomic Shoulder Prosthesis (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630040706001), received between Nov 10, 2022 and Mar 27, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K170910); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Osseointegration Problem2
Patient problems
- Inadequate Osseointegration2
- Joint Laxity1
- Loss of Range of Motion1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 27, 2024Osseointegration Problem; Osseointegration Problem
ABOUT 6 MONTHS AFTER THE PRIMARY SURGERY, THE JOINT WAS VERY UNSTABLE.THE STEM WAS NOT OSSEOINTEGRATED. THE SURGEON IMPLANTED A LARGER STEM AND A LATERALIZED GLENOSPHERE FOR BETTER TENSION AND FIXATION OF THE TUBERCULUM MAJUS. PATIENT HAD A FRACTURE PROXIMAL TO THE HUMERUS WITH INFECTION IN 2022.
Patient problems: Inadequate Osseointegration; Joint Laxity
MAUDE report 18985246 ↗InjuryNov 10, 2022Osseointegration Problem; Osseointegration Problem
REVISION SURGERY PERFORMED AT ABOUT 9 MONTHS AFTER THE PRIMARY SURGERY DUE TO TUBEROSITIES RE-ABSORPTION, WHICH CAUSED PAIN AND LIMITED ROM IN THIS PATIENT WITH PREVIOUS PROXIMAL HUMERAL FRACTURE. DURING THE REVISION, MOBILIZATION OF THE STEM WAS DETECTED. THE SURGERY WAS COMPLETED SUCCESSFULLY BY CONVERTING THE SYSTEM FROM ANATOMICAL TO REVERSE AND IMPLANTING A LATERALIZED GLENOSPHERE.
Patient problems: Inadequate Osseointegration; Loss of Range of Motion
MAUDE report 15770488 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K170910. One submission often covers many models, so check the product and lot details in each record.
- Z-0775-2020 · Nov 4, 2019 · TerminatedMedacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treat
Other Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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